The FDA is discouraging clinicians from using laparoscopic power
morcellation for uterine fibroids because the procedure can cause
undiagnosed uterine cancer to spread, the agency announced on
Thursday. It stopped short of banning the procedure.
An FDA analysis found that roughly 1 in 350 women undergoing
hysterectomy or myomectomy for fibroids has unsuspected uterine
sarcoma. In such cases, laparoscopic morcellation, which involves
cutting tissue into smaller pieces for easier removal, can spread the
cancer within the abdomen and pelvis.
Roughly 50,000 of these procedures are done in the U.S. annually, and
the FDA has received about a dozen reports of cancer being spread.
“We think, in general, the procedure should not be performed,” said
the FDA’s William Maisel, adding that “there still may be individual
patients who benefit.”
The FDA is outrightly recommending against laparoscopic morcellation
in women with suspected or known uterine sarcoma.
Asked to comment, NEJM Journal Watch Women’s Health editor-in-chief
Andrew Kaunitz said, “The current controversy … is focusing
attention on tissue extraction alternatives, including manual or
electronic morcellation within an endoscopic bag, as well as specimen
removal either through laparoscopic-aided mini-laparotomy or through a
vaginal incision. In addition, some hospitals have instituted policies
on the use of electric morcellation during minimally invasive
FDA MedWatch safety alert (Free)
By Kelly Young